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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE

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GENZYME CORPORATION SYNVISC ONE Back to Search Results
Lot Number 218288302
Device Problem Insufficient Information (3190)
Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Weakness (2145); Dizziness (2194); Joint Swelling (2356)
Event Date 11/13/2017
Event Type  Injury  
Event Description
Bilateral knee injections received on (b)(6) 2017. One hour after injections patient experienced pain, swelling, generalized weakness, light headedness, n/v, tingling in feet. Dose or amount: 6 ml millilitre(s). Frequency: other - once. Route: intra-articular. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Diagnosis or reason for use: arthritis of knees.
 
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Brand NameSYNVISC ONE
Type of DeviceSYNVISC ONE
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key7154363
MDR Text Key96177207
Report NumberMW5074280
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number218288302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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